Telemedicine for Reach, Education, Access and Treatment-ongoing

Diabetes Mellitus Clinical Trial

— TREAT-ON  

Official title:

Telemedicine for Reach, Education, Access and Treatment-ongoing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04107935
• Other study ID #: STUDY19080005
• Secondary ID: 1R34DK123370-01
• Status: Terminated
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: December 9, 2022

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes (DM) management requires health care providers to provide patients with the appropriate amount of time, education and support that are necessary for quality care. Unfortunately, this is often impeded by limited access to resources, particularly in rural communities where DM rates are high and providers are scarce. Therefore, study investigators propose addressing these issues by implementing a model of care that includes diabetes educator (DE)-led planned visits with a real-time videoconferencing telemedicine program for ongoing patient support to improve DM outcomes.

Description:

Health care systems need to seek ways through quality improvement, care coordination, and workforce capacity to support quality care. It has been proposed that new models of care coupled with technology are needed. DM provides an ideal model for testing new approaches as the number of people with DM continues to rise, with an inverse shortage of health providers available to meet their needs. Most patients with Type 2 DM (T2DM) are seen in primary care (PC) where providers report barriers to comprehensive care that include limited time, educational resources, added workload and feeling ill-equipped to counsel patients on behavior change. Efforts to restructure PC are underway, like DE-led planned management visits, reported to improve healthy behaviors and outcomes in patients at high risk. DEs are well suited to support the skills, decision making, self-care behaviors, problem solving and active collaboration with the care team that serve as the foundation for diabetes self-management education and key to an effective planned visit. DEs supporting care and self-management education in PC have been shown to improve access and outcomes. For patients to sustain a lifetime of behavior to effectively self-manage, continued support to sustain the ongoing skills, knowledge, and behaviors required to manage their condition is needed. Given the need for enduring support and scarcity of providers, particularly in underserved rural areas, efforts to understand how best to re-design practice to involve DEs in PC and utilize technology to enable and scale engagement in self-management and ongoing support must be considered. The purpose of this application is to evaluate the deployment of Telemedicine for Reach, Education, Access, Treatment and Ongoing Support (TREAT-ON), a DE-driven, PC-based telemedicine model that relies on PC practice redesign to afford access to real-time ongoing support. Investigators hypothesize that the TREAT-ON model will help individuals identified as being high risk in an underserved rural community to achieve and sustain improvements in clinical, psychosocial and behavioral outcomes, and aim to demonstrate the model's viability in terms of feasibility and acceptability to inform future testing of TREAT-ON.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: December 9, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Intervention group: UPMC Health Plan patient-members who are 18-75y, have diagnosis of type 2 diabetes, are considered "high risk" (HbA1c >9%), receiving care at participating Federally Qualified Health Centers, and willing and able to participate in a technology-supported intervention.

• Control group: The control group will be selected from individuals who have already participated in the UPMC Health Plan's Diabetes High Risk Initiative.

Exclusion Criteria:

• Non UPMC Health Plan patients

• Not enrolled in the UPMC Health Plan Diabetes High Risk Initiative

• Less than 18 or greater than 75 years of age

• Unwilling/unable to participate in the telemedicine diabetes education program

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• TREAT-ON
TREAT-ON is a DE-driven self-management and support program that is delivered primarily through a real-time telemedicine videoconferencing platform. Like the usual care intervention, "high risk" patients with DM receiving care in underserved practices will be identified by a nurse practice-based manager (PCBM) and referred to a DE for self management services. Participants will complete an initial face-to-face visit with the DE to assess needs and develop a self-management treatment plan and goals. Via telemedicine videoconferencing, follow-up visits will be delivered by the DE to participants in their homes. Follow-up visits will be used to evaluate and support progress towards meeting and sustaining self-management goals and outcomes.
• Usual Care
A retrospective control group will be formed from individuals who have previously participated in a program called the "Diabetes High Risk Initiative." In this program, patients receiving care in underserved practices are identified by a nurse PBCM to be at high risk for DM complications and/or unplanned care and referred to a DE for self management services delivered through primary care. Patients typically participate in one face-to-face visit with the DE to assess needs and develop self-management goals and then one to two follow-up encounters (generally conducted by telephone) with the PBCM or DE.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycemic Control	Average change in HbA1c every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only one result reported per arm.	Change every 3 months for 12 months.
Secondary	Change From Baseline in Diabetes Self-care Behavior [Diet] Across 3 Month Intervals for 12 Months.	Summary of Diabetes Self-care Activities Measure was used to evaluate self-care with questions about number of days in a week that the participant reports self-care behaviors. Individual items are scored 0 (minimum) to 7 (maximum) for number of days the behavior is performed. The total possible score ranges from 0 to 7. The higher the score for dietary behavior, the better. For this study, average change in scores from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only one result reported per arm.	Change every 3 months for 12 months total.
Secondary	Change From Baseline in Diabetes Distress Across 3 Month Intervals for 12 Months	Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress (represents worse outcome). Possible score range 1 to 6. For this study, average change in scores every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only 1 result reported per arm.	Change every three months for 12 months total
Secondary	Change From Baseline in Diabetes Empowerment Across 3 Month Intervals for 12 Months	Empowerment was measured using the 8-item Diabetes Empowerment Scale-Short Form, which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment (better outcome). For this study, average change in scores every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only 1 result reported per arm.	Change every 3 months for 12 months total
Secondary	Intervention Acceptability	Telemedicine Usability Questionnaire was used to assess telehealth usefulness, ease of use and learnability, interface quality, patient-clinician interaction, reliability, satisfaction and future use and included additional items specific to this study. Individual items are scored on a scale from one to five, with one being strongly disagree to five being strongly agree. Scores are averaged for a possible score range of one to five. The higher the score infers the better the usability of the telehealth service.	12 months
Secondary	Change From Baseline in Medication Adherence Across 3 Month Intervals for 12 Months	Medication adherence was assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). The scales includes 8 items. Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered. For this study, average change in scores every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only 1 result reported per arm.	Change every 3 months for 12 months total